Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
128 participants
INTERVENTIONAL
2011-03-31
2017-07-31
Brief Summary
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To investigate whether progesterone treatment affects the incidence of preterm labor compared to placebo, among women with 2nd trimester bleeding.
The participants will be allocated through randomization to a study or control group. Women in the study group will receive micronized progesterone 200 mg (Utrogestan, company) with an intra-vaginal tablet once daily while the control group will receive placebo. Both women and medical staff will be blinded to group allocation. Treatment will commence on the day of inclusion to the study, but not before 16 weeks and will continue until 36 weeks gestation. Data will be collected after the conclusion of pregnancy regarding the maternal and neonatal outcome.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Utrogestan
micronized progesterone 200 mg (Utrogestan)
micronized progesterone 200 mg (Utrogestan, company) as an intra-vaginal tablet once daily
placebo
placebo
placebo 200mg vaginal tablets
Interventions
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micronized progesterone 200 mg (Utrogestan)
micronized progesterone 200 mg (Utrogestan, company) as an intra-vaginal tablet once daily
placebo
placebo 200mg vaginal tablets
Eligibility Criteria
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Inclusion Criteria
* Gestational age between 13 to 26 weeks
* Vaginal bleeding from uterine origin
* Singleton pregnancy
* Normal clotting tests
* Hemodynamically stable woman
Exclusion Criteria
* Signs of preterm labor
* Fetal malformations incompatible with life
* Uterine malformations and other maternal conditions, i.e. liver disease, breast cancer, active thromboembolic state
* Past preterm birth
18 Years
FEMALE
No
Sponsors
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HaEmek Medical Center, Israel
OTHER
Responsible Party
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Raed Salim
Dr.
Principal Investigators
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RAED SALIM, MD
Role: PRINCIPAL_INVESTIGATOR
HaEmek medical center affiliated to the Rappaport faculty of medicine, Technion, Haifa, Israel
Locations
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Emek medical center
Afula, , Israel
dEP ob/gyn, Hillel Yaffe Medical Center.
Hadera, , Israel
Dep. OB/GYN, The Nazareth Hospital, E.M.M.S
Nazareth, , Israel
Countries
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References
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Salim R, Hakim M, Zafran N, Nachum Z, Romano S, Garmi G. Double-blind randomized trial of progesterone to prevent preterm birth in second-trimester bleeding. Acta Obstet Gynecol Scand. 2019 Oct;98(10):1318-1325. doi: 10.1111/aogs.13641. Epub 2019 Jun 1.
Other Identifiers
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0023-08-EMC
Identifier Type: -
Identifier Source: org_study_id
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